Compare Sterilized Clean vs Sterilized Aseptic Dental Implant Surgery

October 22, 2013 updated by: Andre Chen, Implantology Institute

Sterilized Aseptic Versus Sterilized Clean Field for Dental Implant Placement - Randomized Clinical Control Trial for Non-inferiority Comparison

In patients that require dental implants , does performing the surgery in clean sterile field compared to aseptic field, produces more post-operatory complications, implant morbidity or patient discomfort ?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators intend to compare two types of operatory room preparation (aseptic versus clean), used world wide, for placing dental implants.

The investigators want to see if it has impact on post-operatory healing, osseointegration and success rate of dental implants.

Before Study begins the investigators will perform inter-observer agreement in surgical preparation of the surgical suite, implant placements and operatory-room behavior.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1600
        • University of Lisbon, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All surgeries schedule for implant placement

Exclusion Criteria:

  • Surgeries not made with local anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sterilized Clean Full-Mouth

The operatory room will be prepared with clean instruments but with no aseptic preparation.

Full-mouth dental implants placement will be made, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product.

It will be evaluated the duration of surgery.
Procedure: Sterilized Clean
Operatory room will be prepared clean but not aseptic
Other Names:
  • Clean operatory room
Procedure: Full-Mouth Dental Implants
dental implants for full-mouth implant rehabilitation.
Other Names:
  • Full-mouth rehabilitation
  • Full mouth implant supported rehabilitation
Procedure: Duration of Surgery
it will be measure the amount of time to perform the dental implant surgery. It will be measured from the time that the surgeon does the first incision until the last suture is made.
Other Names:
  • Time for implant placement
Active Comparator: Sterilized Aseptic Full-Mouth

The operatory room will be prepared with sterilized aseptic clean instruments. Full-mouth dental implants placement will be performed and involves meticulous hand washing, use of a sterile field, use of sterile gloves for application of a sterile dressing, and use of sterile instruments and fluid only. Involves the use of only sterile instruments and materials in dressing.

There is no contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or products.

It will be evaluated the duration of surgery.
Procedure: Full-Mouth Dental Implants
dental implants for full-mouth implant rehabilitation.
Other Names:
  • Full-mouth rehabilitation
  • Full mouth implant supported rehabilitation
Procedure: Duration of Surgery
it will be measure the amount of time to perform the dental implant surgery. It will be measured from the time that the surgeon does the first incision until the last suture is made.
Other Names:
  • Time for implant placement
Procedure: Sterilized Aseptic
Operatory room will be prepared totally aseptic
Other Names:
  • aseptic operatory room
Experimental: Sterilized Clean Single

The operatory room will be prepared with clean instruments but with no aseptic preparation.

Single dental implants placement will be made, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or products.

It will be evaluated the duration of surgery.
Procedure: Sterilized Clean
Operatory room will be prepared clean but not aseptic
Other Names:
  • Clean operatory room
Procedure: Duration of Surgery
it will be measure the amount of time to perform the dental implant surgery. It will be measured from the time that the surgeon does the first incision until the last suture is made.
Other Names:
  • Time for implant placement
Procedure: Single Dental Implants
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
Other Names:
  • Dental Fixtures
Active Comparator: Sterilized Aseptic Single

The operatory room will be prepared with clean instruments but with no aseptic preparation.

Single dental implants placement will be made, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product.

It will be evaluated the duration of surgery.
Procedure: Duration of Surgery
it will be measure the amount of time to perform the dental implant surgery. It will be measured from the time that the surgeon does the first incision until the last suture is made.
Other Names:
  • Time for implant placement
Procedure: Sterilized Aseptic
Operatory room will be prepared totally aseptic
Other Names:
  • aseptic operatory room
Procedure: Single Dental Implants
place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
Other Names:
  • Dental Fixtures
Experimental: Sterilized Clean - Partial

The operatory room will be prepared with clean instruments but with no aseptic preparation.

One or more dental implants will be made for partial rehabilitation, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product.

It will be evaluated the duration of surgery.
Procedure: Sterilized Clean
Operatory room will be prepared clean but not aseptic
Other Names:
  • Clean operatory room
Procedure: Duration of Surgery
it will be measure the amount of time to perform the dental implant surgery. It will be measured from the time that the surgeon does the first incision until the last suture is made.
Other Names:
  • Time for implant placement
Procedure: Partial Rehabilitation
two or more implants to support partial rehabilitation
Other Names:
  • partial implant-supported rehabilitation
Active Comparator: Sterilized Aseptic - Partial

The operatory room will be prepared with clean instruments but with no aseptic preparation.

One or more dental implants will be made for partial rehabilitation, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies.

There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product.

It will be evaluated the duration of surgery.
Procedure: Duration of Surgery
it will be measure the amount of time to perform the dental implant surgery. It will be measured from the time that the surgeon does the first incision until the last suture is made.
Other Names:
  • Time for implant placement
Procedure: Sterilized Aseptic
Operatory room will be prepared totally aseptic
Other Names:
  • aseptic operatory room
Procedure: Partial Rehabilitation
two or more implants to support partial rehabilitation
Other Names:
  • partial implant-supported rehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-Operatory Complications
Time Frame: From Implant Placement (Baseline) to 4 weeks after (T1)
Measure the amount of adverse effects in both groups (aseptic vs clean) that happen between time frame baseline to 4 weeks.
From Implant Placement (Baseline) to 4 weeks after (T1)
Osseointegration
Time Frame: At 8 weeks (T2) after Baseline
Measure the ability of dental implants to integrate into bone in both groups (aseptic vs clean)
At 8 weeks (T2) after Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Marginal bone loss
Time Frame: At Final Restoration placement - Expected Average of 12 Weeks after baseline
measure the amount of marginal bone loss at the time of final restoration placement
At Final Restoration placement - Expected Average of 12 Weeks after baseline
Patient Satisfaction
Time Frame: At 2 weeks
measure the amount of post-operatory discomfort of the patient
At 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Implantology Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andre Chen, Msc, University of Lisbon, College of Dentistry
  • Study Director: João Caramês, Phd, University of Lisbon, College of Dentistry
  • Study Chair: João Canta, Msc, University of Lisbon, School of Dentistry
  • Study Chair: Helena Francisco, Msc, University of Lisbon, College of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • II-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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